Analytical method development
and process controls

The responsibilities
of the QC Department

• Raw materials

  Sampling and analysis according to specifications in compliance with pharmacopoeia monographies.

• Environmental monitoring

  Air, water and surface sampling and analysis according to pharmacopoeia monographies.

• Cleaning and Sterilization monitoring

  All CIP/SIP treatments are monitored to ensure that the equipment is ready for production.

• Cells bank analysis

  Batch release testing including safety testing, identity and microbiological strains characterization.

• Protein and plasmid analysis

  Batch release testing including identity, purity, activity, safety (endotoxins, bioburden/ sterility), residual impurities (e.g. DNA, RNA, host cell proteins and media components).

• Product characterization

  Product characterization assays are additional methods that provide supporting data about the products characteristics in addition to release testing.

• Product stability

  All QC methods once developed are shown to be stability indicating. Once this has been demonstrated then ICH based stability studies will be performed.

Our Service Overview

• Development of QC methods

  Including determination of specificity, linearity, limits of detection, limits of quantification

• Qualification and Validation of QC methods

  In compliance with relevant pharmacopoeia, ICH and GMP guidelines

• Stability studies

  In compliance with ICH guidelines

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